NCT02097329已完成1 期
A Phase 1, Open-Label, 3-Period Crossover Study Of The Effect Of An Antacid, A Proton Pump Inhibitor And An H2-Receptor Antagonist On Palbociclib (PD-0332991) Bioavailability Under Fed Conditions In Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
研究概览
简要总结
To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Evidence or history of clinically significant diseases (hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease).
- •Use of tobacco or nicotine containing products within 3 months of screening.
- •A positive urine drug screen.
研究组 & 干预措施
Cohort 1: Palbociclib under fed conditions
Experimental
干预措施: palbociclib commercial free base (Drug)
Cohort 1: Palbociclib under fed conditions
Experimental
干预措施: famotidine (Drug)
Cohort 1: Palbociclib under fed conditions
Experimental
干预措施: rabeprazole (Drug)
Cohort 2: Palbociclib under fed conditions
Experimental
干预措施: palbociclib commercial free base (Drug)
Cohort 2: Palbociclib under fed conditions
Experimental
干预措施: antacid (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: 6 days
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 6 days
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(6 days)
- Apparent Oral Clearance (CL/F)(6 days)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(6 days)
- Apparent Volume of Distribution (Vz/F)(6 days)
- Plasma Decay Half-Life (t1/2)(6 days)
研究者
研究点 (1)
Loading locations...
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